Oxcarbazepine

How to Take:

Take oxcarbazepine exactly as your health care provider prescribes it. Do not change your dose without talking to your provider first. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).

• Check the number of tablets and the strength of the pills you get from the pharmacy. If your provider changes your dose, the strength of your pills may be different. 
• For the immediate release form of oxcarbazepine or Trileptal, swallow the tablets whole. Do not break, crush or chew them. 
  • Take the medicine with or without food, but try to take it the same way each time. 
• For the extended release tablets (Oxtellar XR), take the medicine once a day at the same time every day. Swallow the tablets whole. Do not break, crush or chew them. 
  • It can be taken with water or another liquid. 
  • Take it on an empty stomach about 1 hour before a meal or 2 hours after a meal. 
• For the liquid form, it is generally taken 2 times a day. It can be taken with or without food. 
  • Always check the bottle for the amount of liquid to take and the strength. The strength of the liquid is written as mg per ml. Liquid oxcarbazepine is given as 300 mg per 5 ml, which means there is 60 mg in every ml. 
  • Shake the bottle well before you measure a dose. 
  • Always use an accurate measuring spoon or syringe to make sure the amount is correct. Do not use a regular teaspoon. 
  • After measuring the liquid, drink it directly from the measuring spoon or mix it with a small amount of water and drink it right away. 
• Take only the amount that your provider tells you to take. If you take an extra dose, call your provider for advice. If you take a larger number of pills or overdose, call the poison control center (800-222-1222) or call your hospital emergency room. 

How to Store: 

• Keep and store oxcarbazepine tablets and liquid in their original container at room temperature. 
• Keep them away from heat, moisture and light.
• Keep all medicines out of reach of children. 
• The liquid should be used within 7 weeks of opening the bottle. 

Taking the right amount of seizure medicine on time every day is the most important way to control seizures. Try these steps to help you remember when to take seizure medicine. 

• If you miss a dose, take it as soon as you remember it. If it is almost time for the next dose, skip the missed dose and go back to your usual schedule. 
• Avoid taking 2 doses at the same time or taking extra doses.
• If you are not sure about what to do, call your health care provider's office for advice. Do your best to follow their directions. 
• To avoid missed doses, use a pillbox or set an alarm on your watch or phone. 
• Write down any missed doses in your seizure calendar. Share this with your health care provider at each visit. 

Brain cells normally talk to each other using electrical signals and chemicals. Seizures can happen when the brain cells are not working or firing normally or working faster than normal. Sodium channels are like gates in brain cells that help to spread electrical activity from one cell to another. 

Oxcarbazepine may block sodium channels in the brain to prevent seizures. The exact way the drug works is not fully known. 

How the body absorbs, disgests and breaks down or gets rid of a medicine or food is called metabolism. The way the body metabolizes a medicine affects how often it must be taken. This process can also affect how often you must take a medicine and if it will interact with other medicines. If a person has liver or kidney problems, a person's metabolism may be affected. 

The liver metabolizes oxcarbazepine and the kidneys remove it from the body. 

• People with kidney problems may need to take a lower dose of oxcarbazepine or take it less often. 
• People with severe liver problems should not take the extended release form of oxcarbazepine. 

• Not all seizure medicines work for everyone. Your health care provider may try a series of seizure medicines or combinations of medicines to find one that works best for you. 
• Oxcarbazepine has been tested when used alone to see how well it works to control focal and tonic-clonic seizures. 
  • In one trial, oxcarbazepine was as helpful as carbamazepine. 
  • Two studies that compared phenytoin, valproic acid, and oxcarbazepine found that oxcarbazepine worked as well as the other seizure medicines for adults with focal or generalized tonic-clonic seizures. 
  • In another study, oxcarbazepine and phenytoin were similar in reducing the number of focal or generalized tonic-clonic seizues in children with epilepsy. 
• Oxcarbazepine has been studied as an add on medicine (when given with other seizure medicines). These studies show that this drug reduces seizures and may be given safely with other seizure medicines. 

The most common side effects reported in clinical trials were related to stomach or gastrointestinal symptoms, the nervous system, and vision. These side effects may include:

• Dizziness
• Double vision
• Headache
• Low sodium or salt levels in the bloodstream
• Nausea, upset stomach, indigestion
• Rash
• Tired, sleepy, or drowsy
• Trembling of hands
• Trouble walking
• Trouble with coordination
• Vomiting

Some tips:

• Tell your health care provider if you notice any of these problems. The amount of medicine or when you take it may be changed to help lessen some side effects. 
• Do not stop taking oxcarbazepine or change the amount you take without your provider's advice. 
• If you have just started taking oxcarbazepine (or started taking a larger amount), you may feel tired, drowsy, or uncoordinated. Be careful when driving or doing any activities that require attention or could be dangerous.  
• Do not drink alcohol with this medicine. 

Serious side effects of oxcarbazepine are rare. It is important to be aware of possible reactions and what to do if they happen. Call your provider's office right away if any of these problems occur. 

Allergic Reactions: If you have signs of an allergic reaction - such as a rash, itchiness, swelling or difficulty breathing - call your doctor immediately or go to an emergency room. 

• Tell your provider if you have ever had an allergic reaction to carbamazepine or eslicarbazepine. You could have a similar reaction to oxcarbazepine. 

Hyponatremia: There is a small chance that you may develop a low sodium or salt level in your blood when taking oxcarbazepine (called hyponatremia).

• It is more likely to happen in older adults, but can happen in people at any age. 
• It is more likely to happen within the first few months of taking the medicine, but can happen at any time. 
• You may need to have blood tests to check levels of sodium or salt. 
• Symptoms of hyponatremia may include:
  • Confusion
  • Cramps
  • Dizziness
  • Decreased urination
  • Headaches
  • More seizures
  • Nausea
  • Swelling
  • Tired, lack of energy
  • Vomiting
• Oxcarbazepine may cause these symptoms and not be related to low sodium. Or they may be related to another medicine or health problem. Call your provider if any of these symptoms happen. 

Severe skin reactions: Oxcarbazepine may cause rare but serious skin reactions, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). These conditions may start with a fever and flu-like symptoms. Then a rash develops. Ulcers or lesions of the mucous membranes may be seen and develop into painful blisters blisters. 

• Report any fever or rash to a health care provider, as this can be a life-threatening condition.
• These types of skin reactions happen most commonly in the second or third week after starting the medicine. Though it can happen at other times too. 
• Serious skin reactions are more common in people with a particular type of gene, called "HLA-B*1502 allele. (An allele is a form of a gene that is found on a chromosome. Alleles are involved in deciding whether certain traits passed on from a parent to a child will occur. The tendency to severe drug reactions can be one of these traits.)
  • ​This gene is found in people with ancestry or family lines from broad areas of Asia, including South Asian Indians. People who are Chinese, Thai, Filipino, Malyasian, and Korean may have an increased risk for these skin reactions with oxcarbazepine. 
  • People at risk should be tested for the HLA-B*1502 allele before starting oxcarbazepine. If you test positive, you should avoid using this medicine unless your provider and you decide the benefits are work the risks. 

Suicidal thoughts and behavior: In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relation between many seizure medications (called antiepileptic drugs or AEDs) and suicidal thoughts and behavior. These thoughts and behavior are called suicidality. According to an FDA Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking an AED had suicidality compared to 1 of 1,000 people taking a placebo. The FDA has provided the following information for patients, family members, and caregivers at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.

• Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
• Do not make any changes to the medicines taken without first talking to the prescribing health care provider.
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions
• Contact your health care provider before stopping any seizure medicine. This could possibly lead to worsening of seizures and mood. 

Multi-organ hypersensitivity: This is a serious rare drug reaction that has been seen with oxcarbazepine.

• Typically it starts with a fever, rash, and/or swollen lymph nodes.
• Other body organs may become involved, for example the liver, kidneys, blood, heart or muscles.
• An increase in certain blood cells called eosinophils may be seen. Eosinophils are a type of white blood cells.
• If any of these symptoms or signs occur, get immediate medical help. A rash does not need to occur to be a drug reaction.
• Oxcarbazepine may need to be stopped if no other cause for the symptoms is found. Make sure the doctor treating your seizures is aware of the reaction and is involved in decisions about your seizure medication.

Some medications are found to be helpful for conditions other than the ones approved by the FDA. This is called off-label use. Oxcarbazepine has been used to treat the following conditions off-label:

• A type of facial pain called trigeminal neuralgia (tic douloureux)
• Bipolar disorder (also called manic-depression) 
• Migraines
• Peripheral neuropathy (pain caused by nerve damage)
• Sexual function

• People should not take oxcarbazepine if they are allergic to it or any of its inactive ingredients.
• People who may be at risk for the HLA-B*1502 allele should be tested for this allele before starting oxcarbazepine. This allele occurs more frequently in certain groups of people - such as Chinese, Thai, Filipino, Malaysian, and Korean. People who test positive for the HLA-B*1502 allele should avoid using oxcarbazepine unless your doctor and you decide the benefits outweigh the risks.
• If you have severe liver problems, the extended release form of oxarbazepine is not recommended.
• If you have kidney problems, tell your health care provider. A lower dose of the medicine may be needed so it does not build up to an unsafe level in your body.

Some medicines may affect how another medicine works in your body. When this happens, the choice and amount of medicine needs to be adjusted carefully. 

Oxcarbazepine can interact with:

• Seizures medicines such as phenytoin, carbamazepine, phenobarbital, lamotrigine, and perampanel
• Certain antidepressants
• Antiviral medicines
• Hormonal contraceptives or birth control 

Women taking oxcarbazepine and a hormonal form of birth control should talk to their doctors about other forms of birth control to prevent pregnancy.

Tell your health care providers and pharmacist about all prescription medicines, over-the-counter medicines, vitamins, and other supplements or products you are taking. If you take a drug that may interact with oxcarbazepine, ask if blood tests or other monitoring is needed. 

• Oxcarbazepine is used to treat focal (partial) seizures and generalized tonic-clonic seizures in children, ages 4 to 16 years old. It can be used alone or with another seizure medicine. 
• It is also used with other seizure medicines for focal seizures in children ages 2 to 15 years. 
• The dose of oxcarbazepine used in children is based on weight. The recommended doses may be larger in children than in adults because of differences in how children and adults break down medicines. 

Effect of seizure medicines during pregnancy: In the United States, the FDA assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Oxcarbazepine is listed in Pregnancy Category C. This means that caution is advised, but the benefits of the medicine may outweigh the potential risks.

• Talk to your health are providers if you are pregnant or plan to become pregnant.
• The risk of birth defects is generally higher in children of women who:
  • Take more than one seizure medicine at the same time 
  • Have a family history of birth defects

All women who are capable of becoming pregnant should take at least 0.4 mg (400 mcg) each day of the vitamin called folic acid (also called folate). This vitamin is thought to help prevent birth defects affecting the brain and spinal cord, called neural tube defects. The most common of these is known as spina bifida.  

• Women at high risk of having a child with a birth defect (such as those with a birth defect in a previous pregnancy or taking certain seizure medicines) may be asked to take 4 mg (4,000 mcg) daily before and during pregnancy. 
• Talk to your health care provider about using folic acid and how much to take.
• Start taking this vitamin before you become pregnant. 

Seizures during pregnancy: Some women may have more seizures during pregnancy, because of hormone changes and how seizure medicine is handled by your body. 

• Talk to your health care provider before pregnancy about seizures and if medicine changes may be needed.
• Know when to check blood levels of medicine during and after pregnancy.
• The dose of seizure medicine may need to be adjusted during and after pregnancy. 

Breastfeeding:  Oxcarbazepine is found in breast milk, but it is not likely to cause side effects in babies who are breastfed, especially when the infant is over 2 months old. 

• If you choose to breastfeed, check the baby for drowsiness and keep track of their weight gain and development, especially in younger infants or if you are taking more than one seizure medicine. 
• Talk to your health care team about any concerns that arise and the benefits and risks of breastfeeding. 

Contraception: Oxcarbazepine can lower the amount of some hormonal forms of birth control. This may make the contraceptive or birth control less effective. A woman taking oxcarbazepine and some forms of hormonal birth control may be at greater risk for pregnancy. 

• Tell your health care team and pharamcist if you are taking hormonal birth control such as the pill, injection, or patch. 
• Consider using a barrier type of contraception (such as condoms, cervical caps, diaphrams) or a non-hormonal IUD. 

• Oxcarbazepine appears to be as safe in older adults (65 years and older) as in younger adults.
• The dose of oxcarbazepine in older adults may need to be adjusted. When people are older than 65 to 70, their kidneys usually don't work as well as younger people. Since the kidneys are involved in clearing the body of oxcarbazepine, the medicine may stay in the body longer. 
  • Starting oxcarbazepine at a lower dose and increasing it more slowly may be needed. 
• People of all ages may develop side effects, such as nausea, vomiting, dizziness and drowsiness. Some seniors may be more sensitive to side effects like these. Hyponatremia or low blood sodium may happen more often in older adults taking oxcarbazepine. 
• Report any changes or side effects to your health care team. Some symptoms like dizziness or drowsiness may lead to falls and accidents. 

The best amount is the amount that completely controls seizures without causing side effects. This depends on many factors, which are different for every individual. 

Adults usually are told to start by taking 300 to 600 milligrams (mg) per day, divided into two doses. After about a week, the doctor probably will suggest taking a higher dose. The recommended dosage for most adults is 600 to 1,200 mg per day when oxcarbazepine is used alone. Higher dosages may be necessary when it used with other seizure medicines.

Patients with poor kidney function generally should take only half as much. This also applies to many seniors, too.

Those who have been taking another seizure medicine may be told to continue to take it in the same way as before, or the amount of the other medicine may gradually be reduced over several weeks to months. If the plan is to continue taking another medicine along with oxcarbazepine, blood tests may be needed to check the level of the other medication. Oxcarbazepine sometimes causes it to change.

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Trileptal (oxcarbazepine) is found at:

• http://www.pharma.us.novartis.com/product/pi/pdf/trileptal.pdf

Some of the information may differ in other countries.

Learn how to read a package insert here.